U.S. patent application number 11/348999 was filed with the patent office on 2007-09-13 for surgical instruments and techniques for percutaneous placement of spinal stabilization elements.
This patent application is currently assigned to SDGI Holdings, Inc.. Invention is credited to Jeff R. Justis.
Application Number | 20070213714 11/348999 |
Document ID | / |
Family ID | 38083571 |
Filed Date | 2007-09-13 |
United States Patent
Application |
20070213714 |
Kind Code |
A1 |
Justis; Jeff R. |
September 13, 2007 |
Surgical instruments and techniques for percutaneous placement of
spinal stabilization elements
Abstract
Systems and methods for positioning a connecting element
adjacent the spinal column in minimally invasive procedures include
instruments that guide the connecting element from a location
remote from one or more anchors to a location proximate to the one
or more anchors. The instruments include extensions mountable to
anchors, and inserter instruments mountable to the connecting
element for positioning the connecting element adjacent the anchors
in a minimally invasive procedure. The inserter instruments need
not be mounted to the anchors or to the anchor extensions, and are
operable independently thereof to position the connecting element
into the patient along a minimally invasive insertion path from a
location remote from the anchor extensions.
Inventors: |
Justis; Jeff R.;
(Collierville, TN) |
Correspondence
Address: |
KRIEG DEVAULT LLP
ONE INDIANA SQUARE, SUITE 2800
INDIANAPOLIS
IN
46204-2709
US
|
Assignee: |
SDGI Holdings, Inc.
|
Family ID: |
38083571 |
Appl. No.: |
11/348999 |
Filed: |
February 7, 2006 |
Current U.S.
Class: |
606/86A ;
623/17.16 |
Current CPC
Class: |
A61B 17/7002 20130101;
A61B 17/7089 20130101; A61B 17/7086 20130101; A61B 17/7083
20130101; A61B 34/20 20160201; A61B 2034/2051 20160201; A61B
17/7032 20130101; A61B 17/8866 20130101; A61B 17/7022 20130101 |
Class at
Publication: |
606/061 |
International
Class: |
A61F 2/30 20060101
A61F002/30 |
Claims
1. A system for minimally invasive surgical procedures in a
patient, comprising: a number of anchor extensions each including
an elongated body extending between a distal end and a proximal
end, said body having a length wherein when said distal end is
mounted to at least one anchor engaged to bony structure of the
patient said proximal end is located outside the patient; an
inserter instrument including a proximal handle portion and an
inserter arm extending distally from said proximal handle portion;
and a connecting element for implantation in the body of the
patient, said connecting element releasably engaged to and
extending distally from said inserter arm, wherein said proximal
handle portion and said connecting element extend generally
parallel to one another when said connecting element is engaged to
said inserter arm and said releasable engagement between said
connecting element and said inserter is structured to permit said
connecting element to be pushed through tissue of the patient with
said inserter instrument while maintaining said generally parallel
relationship with said proximal handle portion.
2. The system of claim 1, wherein said number of anchor extensions
includes three or more anchor extensions, each of said anchor
extensions including an anchor releasably engaged to said distal
end thereof.
3. The system of claim 1, wherein said inserter arm includes a
curved profile between said connecting element and said proximal
handle portion.
4. The system of claim 1, wherein said connecting element includes
a leading end and an opposite trailing end, said trailing end being
engageable to said inserter arm and with said connecting element
extending away from said inserter arm to said leading end.
5. The system of claim 4, wherein said leading end is tapered.
6. The system of claim 5, wherein said trailing end is tapered and
includes a notches for engagement with said inserter
instrument.
7. The system of claim 4, wherein said connecting element is linear
between said leading insertion end and said trailing end.
8. The system of claim 1, wherein said inserter arm and said handle
portion are joined at a junction portion forming a general L-shape
with said handle portion extending from said handle portion in a
direction opposite a direction in which said connecting element
extends from said inserter arm.
9. The system of claim 1, wherein said connecting element includes
a lumen extending between and opening at leading and trailing ends
of said connecting element, said lumen being adapted to receive a
guide wire.
10. The system of claim 1, wherein said inserter arm includes a
bore with a locking mechanism therein, said locking mechanism
including a shaft portion extending between an engaging end
adjacent a distal end of said inserter arm and an opposite end
coupled to an actuating member adjacent a proximal end of said
inserter arm, said actuating member being pivotally mounted to said
inserter instrument for movement between an unlocked position
wherein said engaging end projects from said distal end of said
inserter arm to receive said connecting element to a locked
position wherein said actuating member moves said engaging end into
said bore of said inserter arm, said inserter arm engaging said
engaging end as said engaging end is moved therein to engage said
connecting element to said engaging end.
11. The system of claim 10, wherein said engaging member includes a
pair of arms and a hinge portion therebetween, said inserter arm
pivoting said arms toward one another to engage said connecting
element therebetween when said actuating member is moved to said
locked position.
12. The system of claim 10, wherein said connecting element is
elongated and extends between a leading insertion end and a
trailing end and said engaging end is engaged to said trailing
end.
13. The system of 10, wherein said actuating member is coupled to
said inserter instrument with a coupling mechanism, said coupling
mechanism including at least one link member having a first end
pivotally coupled to said actuating member and a second end
pivotally coupled to said inserter arm.
14. The system of claim 13, wherein said actuating member is
pivotally coupled at one end thereof at a junction of said handle
portion and said inserter arm, and in said locked position said
actuating member extends along said handle portion and in said
unlocked position said actuating member is pivoted away from said
handle portion about said pivotal connection.
15. A system for minimally invasive surgical procedures in a
patient, comprising: at least one anchor extension including an
elongated body extending between a distal end and a proximal end,
said body having a length wherein when said distal end is mounted
to an anchor engaged to bony structure of the patient said proximal
end is located outside the patient; an inserter instrument
including a proximal handle portion and an inserter arm having a
proximal end joined to said proximal handle portion, said inserter
arm having a curved profile extending from said proximal end to a
distal end spaced from said handle portion; and a connecting
element for implantation in the body of the patient, said
connecting element rigidly engageable to said inserter arm, wherein
said connecting element includes a generally linear profile
extending distally from said distal end of said inserter arm when
engaged thereto.
16. The system of claim 15, wherein said handle portion extends
along an axis that is generally parallel to said connecting element
when said connecting element is engaged to said inserter arm.
17. The system of claim 15, wherein said anchor extension defines a
space adjacent to said anchor when mounted thereto, said connecting
element being sized for positioning through said space with said
inserter instrument in a transverse orientation to said anchor
extension.
18. The system of claim 17, wherein said anchor extension includes
a first member for engagement with said anchor and a second member
moveable relative to said first member into said space to contact
said connecting element and move said anchor and said connecting
element toward one another with said first member engaged to said
anchor.
19. A surgical system, comprising: an anchor including a distal
bone engaging portion and a proximal connecting element engaging
portion; an extension releasably engageable to said connecting
element engaging portion, said extension extending along a
longitudinal axis and comprising: an inner sleeve along the
longitudinal axis including a pair of distal fingers engageable to
said connecting element engaging portion; an outer sleeve along the
longitudinal axis about said inner sleeve, said outer sleeve
moveable distally relative to said inner sleeve from a first
configuration wherein said fingers are movable to receive and
release said connecting element engaging portion therebetween and a
second configuration wherein said outer sleeve engages said fingers
in clamping engagement with said connecting element engaging
portion; and a reducing actuator rotatably mounted adjacent a
proximal end of said outer sleeve in threaded engagement about a
threaded section adjacent a proximal end of said inner sleeve,
wherein rotation of said reducing actuator displaces said inner
sleeve proximally relative to said outer sleeve and through said
reducing actuator.
20. The system of claim 19, wherein said outer sleeve includes a
locking mechanism having a locking position wherein said locking
mechanism includes a first projection that engages a recess in an
outer wall of said inner sleeve to resist said inner sleeve moving
distally relative to said outer sleeve, said locking mechanism
further including a second projection that interferes with a
protrusion extending from said inner sleeve to resist said inner
sleeve moving proximally relative to said outer sleeve.
21. The system of claim 20, wherein said locking mechanism is
movable to a release configuration wherein said inner sleeve is
movable distally and proximally relative to said outer sleeve.
22. The system of claim 21, wherein said recess and said protrusion
of said inner sleeve are located in a non-threaded flat wall
surface extending along said threaded section of said inner
sleeve.
23. The system of claim 21, wherein said locking mechanism includes
an elongated locking button pivotally coupled to said outer sleeve,
said first and second projections being located adjacent a proximal
end of said button, said button being movable by depressing a
distal end of said button and rotating said button about a
connection therewith to said outer sleeve located between said
distal and proximal ends of said button.
24. The system of claim 19, wherein said inner sleeve defines a
passage extending therethrough and opening at a proximal end
thereof for receiving an engaging member for engaging said
anchor.
25. A method for stabilizing a portion of a spinal column,
comprising: engaging at least one anchor to at least one vertebra;
providing an extension from the at least one anchor with the
extension extending proximally from the at least one anchor to a
proximal end remote from the at least one anchor; and guiding a
connecting element through tissue of the patient to a space
adjacent the anchor with an inserter instrument, wherein neither
the connecting element nor the inserter instrument are engaged to
or guided by the extension to the space.
26. The method of claim 25, further comprising: engaging a trailing
end of the connecting element to an end of the inserter instrument
with the connecting element extending from the inserter to a
leading end of the connecting element spaced from the inserter
instrument.
27. The method of claim 26, wherein the leading end of the
connecting element is tapered.
28. The method of claim 26, wherein engaging the trailing end of
the connecting element includes actuating a locking mechanism of
the inserter instrument to secure an engaging end of the locking
mechanism about the trailing end of the connecting element.
29. The method of claim 26, wherein engaging the trailing end of
the connecting element includes engaging the connecting element in
a generally parallel relation with a proximal handle portion of the
inserter instrument.
30. The method of claim 29, wherein the inserter instrument
includes an inserter arm that is curved between the proximal handle
portion and the connecting element.
31. The method of claim 25, wherein the at least one anchor
includes three or more anchors each of which includes an extension
extending proximally from the anchor to a respective proximal end
of the extension.
32. The method of claim 31, wherein guiding the connecting element
includes serially advancing the connecting element adjacent to a
receiver of a first one of the anchors and then adjacent to a
second receiver of a second one of the anchors and then adjacent to
a third receiver of a third anchor so that the connecting element
extends between the receivers of the anchors.
33. The method of claim 32, further comprising manipulating the
extensions to seat the connecting element into the receivers of the
respective anchors.
34. The method of claim 33, further comprising engaging the
connecting element seated in each of the receivers to the receiver
of the respective anchor.
35. The method of claim 33, wherein the extensions each include a
first member with a pair of arms clamped to opposite sides of the
respective anchor, the pair of arms forming a space therebetween
for receiving the connecting element, the extension each further
including a second member proximal of the space, and manipulating
the extensions includes distally advancing the second member into
contact with the connecting element.
36. A method for stabilizing a portion of a spinal column,
comprising: engaging at least one anchor to each of a first
vertebra and a second vertebra; providing an extension from each of
the at least one anchors with the extension extending proximally
from the respective anchor to a proximal end remote from the at
least one anchor, wherein the extension includes a first member
having a distal portion engaged to the anchor forming a space
adjacent to the respective anchor and a second member proximal of
the space; engaging a connecting element with a distal end of an
inserter arm of an inserter instrument, the inserter instrument
including a proximal handle portion extending from a proximal end
of the inserter arm; guiding the connecting element through tissue
of the patient to the space formed by each of the anchor extensions
with the proximal handle portion of the inserter instrument; and
advancing the second member of each of the extensions into contact
with the connecting element to seat the connecting element into
each anchor.
37. The method of claim 36, wherein the handle portion extends
generally parallel to the connecting element when the connecting
element is engaged to the distal end of the inserter arm.
38. The method of claim 36, wherein neither the inserter instrument
nor the connecting element are engaged to either of the extensions
while guiding the connecting element through tissue at least until
the connecting element is in the space formed by at least one of
the anchor extensions.
39. The method of claim 38, wherein advancing the second member of
each of the extensions includes rotating a reducing actuator
relative to the second member and about a threaded section of the
first member to proximally displace the first member relative to
the second member.
40. The method of claim 39, wherein the distal portion of the first
member includes a pair of arms and a sleeve portion extending
proximally from the pair of arms and the second member includes an
outer sleeve positioned about the first member and movable relative
thereto to force the pair of arms into clamping engagement with the
respective anchor.
41. The method of claim 40, wherein the pair of arms of the first
member include flanged ends extending therealong adjacent a distal
end thereof for securely clampingly engaging the anchor
therebetween when a distal end portion of the outer sleeve is
positioned about the flanged ends.
42. The method of claim 40, wherein a distal end of the outer
sleeve includes opposite, distally extending projecting members
located between the pair of arms of the first member on respective
sides of the pair of arms for contacting the connecting element
when advancing the second member.
Description
BACKGROUND
[0001] Various devices and methods for stabilizing bone structures
have been used for many years. For example, the fracture of an
elongated bone, such as a femur or humerus, can be stabilized by
securing a plate to the fractured bone across the fracture. The
plate extends across the fractured area and thus stabilizes the
fractured components of the bones relative to one another in a
desired position. When the fracture heals, the plate can be removed
or left in place, depending on the type of plate that is used.
[0002] Another type of stabilization technique uses one or more
elongated rods extending between components of a bony structure and
secured to the bony structure to stabilize the components relative
to one another. The components of the bony structure are exposed
and one or more bone engaging fasteners are placed into each
component. The elongated rod is then secured to the bone engaging
fasteners in order to stabilize the components of the bony
structure.
[0003] One problem associated with the above described
stabilization structures is that the skin and tissue surrounding
the surgical site must be cut, removed, and/or repositioned in
order for the surgeon to access the location where the
stabilization device is to be installed. This repositioning of
tissue causes trauma, damage, and scarring to the tissue. There are
also risks that the tissue will become infected and that a long
recovery time will be required after surgery for the tissue to
heal.
[0004] Minimally invasive surgical techniques are particularly
desirable in, for example, spinal and neurosurgical applications
because of the need for access to locations deep within the body
and the presence of vital intervening tissues. The development of
percutaneous minimally invasive spinal procedures has yielded a
major improvement in reducing recovery time and post-operative pain
because they require minimal, if any, muscle dissection and can be
performed under local anesthesia. These benefits of minimally
invasive techniques have also found application in surgeries for
other locations in the body where it is desirable to minimize
tissue disruption and trauma. There remains a need for further
improvements instruments and methods for stabilizing bony
structures using minimally invasive techniques.
SUMMARY
[0005] Systems and methods for positioning a connecting element
adjacent the spinal column in minimally invasive surgical
procedures include an inserter instrument and one or more anchor
extensions removably engaged to one or more anchors engageable to
the spinal column. The inserter instrument can be engaged to the
connecting element and employed to insert the connecting element
through tissue of the patient in a minimally invasive surgical
procedure to a location adjacent to the one or more anchors with
neither the connecting element nor the inserter instrument
mechanically engaged with the extensions. Accordingly, the
connecting element can be guided to a location proximate the
anchors using freehand type techniques aided by image guided
navigation, guidance structures, and/or tactile feel to provide
cues to the surgeon during insertion. Once the connecting element
is located adjacent the anchors, the extensions can be operable to
seat the connecting element in the anchors for engagement of the
connecting element to the anchors.
[0006] Related features, aspects, embodiments, objects and
advantages of the present invention will be apparent from the
following description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] FIG. 1 is a perspective view of a system for positioning a
connecting element in a patient in minimally invasive surgical
procedures with the connecting element remotely positioned relative
to the anchors and anchors extensions.
[0008] FIG. 2 is the system of FIG. 1 with the connecting element
adjacent two of the anchors and anchor extensions of the
system.
[0009] FIG. 3 is the system of FIG. 1 with the connecting element
adjacent all the anchors and anchor extensions of the system.
[0010] FIG. 4 is a perspective view in partial section of a
proximal portion of an inserter instrument with a latch mechanism
in an open position.
[0011] FIG. 5 is a perspective view in partial section of a distal
portion of the FIG. 4 inserter instrument when the latch mechanism
is in an open position.
[0012] FIG. 6 is a perspective view in partial section of the
proximal portion of the inserter instrument of FIG. 4 with the
latch mechanism in a closed position
[0013] FIG. 7 is a perspective view in partial section of the
distal portion of the inserter instrument of FIG. 4 when the latch
mechanism is in a closed position.
[0014] FIG. 7A is a view showing engagement of the locking
mechanism of the inserter instrument with the connecting
element.
[0015] FIG. 8 is an elevation view of an extension in partial
section and in a loading configuration where it is in removable
engagement to an anchor.
[0016] FIG. 9 is an elevation view of the extension of FIG. 8 in a
starting configuration where it is securely engaged to the
anchor.
[0017] FIG. 10 is a perspective view of the extension and anchor of
FIG. 9.
[0018] FIG. 11 is a perspective view of the extension of FIG. 8 in
partial section and manipulated to a seating configuration to seat
a connecting element in the anchor.
[0019] FIG. 12 is a perspective view of a first member of the
extension of FIG. 8.
[0020] FIG. 13 is a side elevation view of the first member of FIG.
12.
[0021] FIG. 14 is a longitudinal section view of a distal portion
of the first member of FIG. 12.
[0022] FIG. 15 is an elevation view in partial section of a
proximal end portion of the first member of FIG. 12.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0023] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended. Any such alterations and further modifications in the
illustrated devices, and such further applications of the
principles of the invention as illustrated herein are contemplated
as would normally occur to one skilled in the art to which the
invention relates.
[0024] Systems and methods for insertion of a connecting element
for connection with anchors engaged to bony parts of the body are
provided. In one form, the systems include at least one anchor
extension extending from at least one anchor engaged to the bony
part of the body. An inserter instrument is engaged to the
connecting element and is operable to position the connecting
element through tissue of the patient from a location remotely
positioned from the at least one anchor and anchor extension to a
location adjacent to or within the anchor where the connecting
element can be secured to the anchor. The anchor and connecting
element can each be positioned into the patient in minimally
invasive procedures, minimizing trauma and surgical risks to the
patient and promoting rapid post-operative recovery. However,
applications in non-minimally invasive surgeries are also
contemplated.
[0025] In another form, the systems and methods include at least
one extension extending from an anchor engaged to the spinal column
or other anatomical structure in a patient. A connecting element is
engaged to an inserter instrument, and the inserter instrument is
movable without a mechanical association with the at least one
extension to position the connecting element adjacent to a space
defined by the extension adjacent to the anchor. The extension is
operable to displace the connecting element in the space to seat
the connecting element in the anchor for engagement to the
anchor.
[0026] In a further form, the systems and methods include an
inserter instrument engageable to a connecting element. The
inserter instrument includes a handle portion at a proximal end
thereof and the connecting element extends distally from the
inserter instrument in a generally parallel relation to the handle
portion.
[0027] In another form, the inserter instrument includes an
inserter arm having a proximal handle portion extending therefrom
in a first direction and a connecting element extending from a
distal end thereof in a second direction opposite the first
direction. The inserter arm can be curved between the handle
portion and the distal end. The inserter instrument can also
include a latch mechanism to releasably secure the connecting
element to the distal end of the inserter arm.
[0028] In another form, the systems and methods include an inserter
instrument having a handle portion, a curved inserter arm extending
from the handle portion to a distal end, and an elongated, linear
connecting element extending from the distal end of the inserter
arm.
[0029] In a further form, the systems and methods include at least
one anchor engageable to at least one vertebral body and an
extension extending proximally from the at least one anchor to a
proximal end of the extension. An inserter instrument includes a
connecting element engaged thereto and is operable to position the
connecting element through tissue to a location adjacent to the at
least one anchor with neither the inserter nor the connecting
element mechanically engaged or mechanically associated with the
extension as the connecting element is positioned in the body of
the patient.
[0030] In yet another form, the systems and methods include three
or more anchors engageable to respective ones of three or more
vertebral bodies and extensions extending proximally from
respective ones of the anchors to a proximal end of the respective
extension. An inserter instrument includes a connecting element
engaged thereto and is operable to position the connecting element
through tissue and serially between locations adjacent the at least
three anchors with neither the inserter instrument nor the
connecting element mechanically engaged or mechanically associated
with any of the extensions as the connecting element is positioned
in the body of the patient.
[0031] Referring now to FIGS. 1-3, there is shown a minimally
invasive surgical system 10 that includes an inserter instrument
20, four anchor extensions 100a, 100b, 100c, 100d (collectively and
individually referred to herein as anchor extensions 100) and an
elongated connecting element 200. Anchor extensions 100a, 100b,
100c, 100d are releasably mountable to respective ones of the
anchors 300a, 300b, 300c, 300d (collectively and individually also
referred to herein as anchors 300.) Anchors 300a, 300b, 300c, 300d
are engaged to respective ones of the vertebrae V1, V2, V3, V4.
Extensions 100 can include a length extending proximally from the
respective anchors 300 so that at least the proximal ends thereof
are located outside a respective wound or incision in the patient
through which a respective one of the anchors 300 is positioned to
engage the respective vertebra.
[0032] Inserter instrument 20 is movable along a percutaneous
insertion path that starts at a location remote from the extensions
100 through skin and tissue of the patient to position connecting
element 200 in a location adjacent the anchors 300. Inserter
instrument 20 is operable to position the connecting element 200
with neither the connecting element 200 nor the inserter instrument
20 mechanically engaged or associated with any of the extensions
100 at least during the initial insertion.
[0033] Connecting element 200 can be an elongated brace, rod or
shaft that is generally linear along its length to facilitate
placement between three or more anchors. Other embodiments
contemplate that connecting element 200 can be curved along all or
a portion of its length. It is also contemplated that connecting
element 200 can include any configuration known for a rod, implant,
or fastener, so long as connecting element 200 is insertable using
inserter instrument 20. Further, connecting element 200 can be
non-rigid, elastic and/or super-elastic and in the form of a cable,
band, wire, or artificial ligament that is used in tethering,
guiding, or other surgical procedures. Connecting element 200 can
be percutaneously or non-percutaneously inserted with inserter
instrument 20 to a location adjacent connecting element engaging
portions of one or more anchors engaged to a bony structure in the
body of an animal subject to stabilize the bony structure.
[0034] In the illustrated embodiment, connecting element 200 is a
rigid linear rod that forms an extension of inserter arm 22 of
inserter instrument 20 along an axis I defined by connecting
element 200. However, it is contemplated that connecting element
200 can have one or more offset portions or a curvature that varies
or is compounded along its length. In the illustrated embodiment,
inserter instrument 20 includes a handle portion at a proximal end
of inserter arm 22 that extends along an axis A. In one embodiment,
axis A is generally parallel to axis I, and inserter arm 22 is
curved between handle portion 24 and connecting element 200.
[0035] Connecting element 200 in FIG. 1 is inserted via the
inserter instrument 20 to a location adjacent to anchors 300 where
the connecting element 200 can be engaged to anchors 300 to
stabilize the respective vertebrae V1, V2, V3 and V4. The inserter
instrument 20 can be employed without mechanically engaging or
associating the inserter instrument 20 or connecting element 200
with extensions 100 as the connecting element is placed through the
skin and tissue of the patient. Insertion of connecting element 200
can be guided by fluoroscopic imaging techniques, tactile feel and
indications, and/or other suitable arrangements. Examples of
imaging techniques are disclosed in U.S. Pat. No. 6,226,548, for
example, which is incorporated herein by reference in its
entirety.
[0036] In FIG. 1 the leading end 202 of connecting element 200 is
shown in an approach to anchor 300a with trailing end 204 of
connecting element 200 engaged to a distal end of inserter arm 22.
Extension 100a forms a space 102a adjacent anchor 300a for
receiving connecting element 200. By grasping handle portion 24,
the surgeon can manipulate leading end 202 and connecting element
200 through the tissue of the patient and through space 102a toward
space 102b formed between extension 100b and anchor 300b for
placement therethrough, as shown in FIG. 2. Serial advancement of
connecting element 200 through spaces 102c and 102d formed between
extensions 100c and 100d and the respective anchors 300c, 300d can
continue as shown in FIG. 3. When connecting element 200 is
positioned between the desired number of anchors, connecting
element 200 can be engaged to the anchors with a suitable engaging
member, such as a set screw, nut or other engaging member. In a
further embodiment, connecting element 200 is seated relative to
the anchors by operation of one or more of the extensions 100
before engaging connecting element 200 to anchors 300. Such seating
can take the form of a spinal reduction procedure where one or more
vertebrae are pulled or moved into alignment, and then engaged and
maintained in this alignment by engagement of connecting element
200 thereto via the anchors 300.
[0037] In one embodiment, one or more of the extensions 100a, 100b,
100c, 100d can include a first member for engaging the respective
anchor 300 and a second member movable relative to the first member
engaged to the anchor to reduce or seat the connecting element for
engagement with one or more of the anchors 300. After connecting
element 200 is placed in the respective space 102 between the
anchor and its respective extension, the one or more anchor
extensions 100 with reduction capability can be manipulated so that
the second member and the anchor 300 move relative to one another
to seat the connecting element 200 relative to the anchor. Engaging
members can be delivered through the respective extensions to
engage the connecting element 200 to the respective anchors
300.
[0038] Anchors 300 include a bone engaging portion 302 and a
connecting element engaging portion 304. In the illustrated
embodiment, bone engaging portion 302 is a bone screw with a
threaded shank to engage the bony structure of the underlying
vertebra. Connecting element engaging portion 304 can be a receiver
having a U-shape formed by a pair of opposing arms defining a
longitudinal passage alignable along insertion axis I. The arms
further define a proximal/distally extending opening that opens at
a proximal end of the arms to receive a set screw (not shown) to
secure connecting element 200 in the passage with connecting
element 200 extending from the respective anchor 300 along
insertion axis I. Bone engaging portion 302 can be pivotally
received in or coupled to connecting element engaging portion 304
through a distal opening thereof, and structured to interact
therewith to provide anchor 300 with multi-axial capabilities that
permits either a selected number of positions or an infinite number
of positions of bone engaging portion 302 relative to connecting
element engaging portion 304.
[0039] Other forms for anchors 300 are contemplated, including
uni-axial and uni-planar bone screws. The bone engaging portion 302
can be in the form of a spike, staple, fusion device, cannulated
screw, fenestrated screw, interbody device, intrabody device,
clamp, plate, suture anchor, bolt, pin or other bone engaging
member. The connecting element engaging portion 304 can be in the
form of a saddle, yoke, eye-bolt or through-hole, side opening
member, bottom opening member, top-opening member, eyelet, or any
other structure engageable to the connecting element.
[0040] Referring now further to FIGS. 4-7, there is shown further
details of inserter instrument 20. In FIGS. 4-5, inserter
instrument 20 is in an open position to receive or release
connecting element 200, and in FIGS. 6-7 inserter instrument 20 is
in a closed or locked position for engaging the connecting element
200 to inserter arm 22. Inserter instrument 20 includes handle
portion 24 extending from a proximal end 26 of inserter arm 22.
Inserter arm 22 extends transversely to handle portion 24 and its
proximal portion forms generally an "L" shape with handle portion
24 adjacent a proximal end 26 of inserter arm 22. Handle portion 24
can be sized and shaped to receive the palm of a user's handle and
smoothly contoured to facilitate manual control of inserter
instrument 20.
[0041] Inserter arm 22 and handle portion 24 come together at a
junction portion 28 formed by a frame of inserter instrument 20.
Inserter arm 24 can be tapered in cross-sectional size from
proximal end 26 to a narrower distal end 27. Junction portion 28
includes an actuating member 30 pivotally coupled at an upper or
proximal side of the frame at junction portion 28 for easy access
by the user of inserter instrument 20. Actuating member 30 is
coupled to and operates a locking mechanism 34 that extends through
inserter arm 22 to remotely secure and release the connecting
element 200 to the distal end of inserter arm 22. Actuating member
30 extends from its pivotal connection with the frame at junction
28 toward handle portion 24, and can have an open position shown in
FIG. 4 where actuating member 30 extends upwardly from handle
portion 24, and can be pivoted relative to handle portion 24 and
inserter arm 22 to the closed or locked position shown in FIG. 6
where actuating member 30 extends along the portion of the frame
extending between inserter arm 22 and handle portion 24.
[0042] Locking mechanism 34 is coupled with actuating member 30 so
that movement of actuating member 30 in turn translates into
movement of locking mechanism 34. Locking mechanism 34, in the
illustrated embodiment, includes a proximal end cap 36 (FIGS. 4 and
6) protruding or located proximally of inserter arm 22, and a shaft
portion 38 extending distally from end cap 36 through bore 50 of
inserter arm 22 to a distal engaging end 40 (FIGS. 5 and 7)
opposite end cap 36. Actuating member 30 is pivotally coupled with
end cap 36 at a pivot end 37.
[0043] Actuating member 30 is further pivotally coupled with
inserter 20 at junction 28 with a coupling mechanism 52.
Specifically, actuating member 30 provides an over-center type
lever or latch that is operable to displace locking mechanism 34
distally and proximally in inserter arm 22. Actuating mechanism 30
includes opposite ears 31 pivotally coupled with one end 54a of
respective link members 54 of coupling mechanism 52. A cross member
33 extends between ears 31 through an opening of the frame at
junction portion 28. The other end 54b of link members 54 are each
pivotally coupled with inserter arm 22 adjacent proximal end 26.
Accordingly, when actuating member 30 is moved as indicated by
arrow 60, end cap 36 and locking mechanism 34 are displaced
proximally as indicated by arrow 61 from the position in FIG. 4 to
the position shown in FIG. 6.
[0044] In the closed position, link members 54 are generally
orthogonally oriented to actuating member 30, as shown in FIG. 6.
Contact between a convex end of link member 54 and a concave
surface 35 along actuating member 30 can maintain actuating member
30 in the closed position until sufficient force is applied in the
direction opposite arrow 60 to pivot link member 54 and actuating
member 30 about their respective pivotal coupling locations to the
orientations shown in FIG. 4.
[0045] As shown in FIGS. 5 and 7, engaging end 40 of locking
mechanism 34 includes a first arm 42 and a second arm 44 coupled to
one another about an integral or living hinge 43. Each of the arms
42, 44 includes a distal end member 46, 48, respectively, that
project from distal end 27 of inserter arm 22 when actuating member
30 is in the open position of FIG. 5. In this position, arms 42, 44
can move relative to one another by flexing about hinge 43 and
permit insertion of trailing end 204 of connecting element 200
therebetween. Actuating member 30 is moved to the closed position
to displace shaft portion 38 in bore 50 and retract arms 42, 44
into bore 50 and into contact with the inner wall surface adjacent
distal end 27 of inserter arm 22 as shown in FIG. 7. A projection
49 extending from arm 42 can be received in a slot 51 along bore 50
to maintain locking mechanism 34 in alignment as it is moved along
bore 50 into and out of inserter arm 22. Distal end members 46, 48
are maintained in respective receptacles 208, 210 of connecting
element 200, as shown in FIG. 7A, to securely engage connecting
element 200 to inserter instrument 20.
[0046] Other configurations for engaging end 40 are also
contemplated. For example, engaging end 40 can be provided as a
collet with bifurcated wall portions or other radially expandable
and contractable structure to grippingly engage connecting element
200 thereto. In a further form, locking mechanism 34 can include a
lumen 53 extending along and opening between arms 42, 44 and at the
end of end cap 36 to receive a guide wire or other guiding
structure. Connecting element 200 can further be provided with a
lumen 212 therethrough that forms an axial extension of lumen 53,
permitting connecting element 200 and inserter instrument 20 to be
guided percutaneously over a guide wire while engaged to one
another. Sidewall holes 64 in inserter arm 22 are in communication
with the central bore 50 thereof, further facilitating cleaning and
sterilization and removal of any biomaterial that may be trapped
therein.
[0047] Referring now to FIGS. 8-11, one embodiment of the anchor
extensions 100 is shown engaged to an anchor 300. Anchor extension
100 includes a first member in the form of an inner sleeve
positioned within outer sleeve 101. Anchor extension 100 also
includes a second member in the form of an outer sleeve 101
extending along an elongated body 104. Space 102 is formed distally
of outer sleeve 101 between flanged ends 164, 165 of inner sleeve
150.
[0048] With respect to outer sleeve 101, elongate body 104 includes
elongated intermediate slots 108a, 108b extending and opening along
opposite sides thereof. Slots 108a, 108b extend between a proximal
end 109 and a distal end 110. Body 104 includes a distal end
portion 105 that forms a wall that extends completely therearound
in form fitting and sliding engagement with flanged ends 164, 165.
Body 104 includes a length extending from distal end portion 105 to
an enlarged proximal end portion 112. Proximal end portion 112
includes opposite flat wall surfaces 114a, 114b and a release
button 116 pivotally housed in proximal end portion 112 in each of
the wall surfaces 114a, 114b (only one button 116 shown.) Opposite
wall surfaces 118a, 118b of proximal end portion 112 extend between
flat wall surfaces 114a, 114b.
[0049] Proximal end portion 112 further includes an end collar 120
having a reducing actuator 122 rotatably captured thereto. In the
illustrated embodiment, reducing actuator 122 includes a bearing
hub 124 that extends between reducing actuator 122 and an inner
wall surface of end collar 120 to rotatably and axially retain
reducing actuator 122 on outer sleeve 101. Accordingly, reducing
actuator 122 can be rotated relative to outer sleeve 101 while
being axially retained in position thereon. Reducing actuator 122
can extend proximally from end collar 120 for easy access and
manipulation during the surgery. Reducing actuator 122 can be
rotated manually, or can be configured to engage a tool. For
example, in the illustrated embodiment reducing actuator 122 is
configured like a nut to receive a correspondingly shaped tool to
facilitate application of rotational forces. Other embodiments
contemplate other arrangements suitable for manual grasping and/or
grasping by a tool.
[0050] Distal end portion 105 includes distal projecting members
106a, 106b extending therefrom on opposite sides of body 104 and
between the flanged ends 164, 165 of inner sleeve 150. Body 104
further defines distal slots 128a, 128b aligned with respective
ones of the intermediate slots 108a, 108b and extending therefrom
toward the distal end portion 105. Flanged ends 164, 165 extend
through distal slots 128a, 128b as inner sleeve 150 is moved
proximally relative outer sleeve 101, as shown in FIG. 11. Wall
portions 140a, 140b extend between respective ones of the slots
108a, 128a and slots 108b, 128b. Body 104 also defines proximal
slots 130a, 130b aligned with respective ones of the slots 108a,
108b and extending proximally therefrom toward the proximal end
portion 112.
[0051] Anchor extension 100 further includes inner sleeve 150
positioned in a bore extending through outer sleeve 101. Inner
sleeve 150, shown removed from outer sleeve 101 in FIGS. 12-13,
includes a tubular body 158 defining distal fingers 154, 155.
Fingers 154, 155 are separated by a slot 157 to facilitate fingers
154, 155 moving toward and away from another to capture anchor 300
therebetween. In their normal position, fingers 154, 155 are flared
distally away from one another in non-parallel relation by an angle
B both to receive anchor 300 therebetween and when engaged to
anchor 300. Fingers 154, 155 include distal flanged ends 164, 165,
respectively, that project outwardly for axial sliding engagement
with distal end portion 105 of outer sleeve 101.
[0052] As also shown in FIG. 14, flanged ends 164, 165 farther each
include an internal lip 166, 167 that abuttingly engages an
adjacent proximal end of the anchor 300 received therein. The
internal lips 166, 167 can each include a longitudinally extending
concave surface, such as surfaces 172, 173, respectively, that
extend along the passage defined between fingers 154, 155 to
facilitate placement of a set screw or other engaging member
thereby and into the anchor 300 engaged between fingers 154, 155.
Flanged ends 164, 165 each further include a projection or nub 166,
167 distally of the respective lips 166, 167 that engage an
adjacent recess or detent in anchor 300 when flanged ends 164, 165
are clamped to the connecting element engaging portion 304.
[0053] Flanged ends 164, 165 each further include a concavely
curved inner wall portions 170, 171 that form an enlarged space
between fingers 154, 155 extending in a direction that is
transversely oriented to fingers 154, 155. Inner wall portions 170,
171 are spaced proximally from internal lips 166, 167 in order to
be located proximally of connecting element engaging portion 304 of
the anchor 300 when flanged ends 164, 165 are clamped thereto. This
enlarged space defined by wall portions 170, 171 can be employed to
allow passage of a connecting element through space 102 between
fingers 154, 155 even if the connecting element has an enlarged or
non-uniform cross-section along a portion of its length. Examples
of such connecting elements are discussed in U.S. Patent
Application Publication No. 2005/0171540, which is incorporated
herein by reference in its entirety.
[0054] Fingers 154, 155 also each include a projecting member 152,
153, respectively, extending therefrom through respective ones of
the slots 108a, 108b of outer sleeve 101. Projecting members 152,
153 can maintain the inner and outer sleeves 101, 150 in alignment
with one another as they are axially moved relative to one other
and to resist rotation of inner sleeve 150 relative to outer sleeve
101. As outer sleeve 101 is advanced distally along fingers 154,
155, distal end portion 105 extending about fingers 154, 155
contacts the outer surfaces of flanged ends 164, 165 and biases
flanged ends 164, 165 into engagement with anchor 300. The outer
surfaces of fingers 154, 155 can project outwardly along
intermediate portions 186, 187 between flanged ends 164, 165 and
projecting members 152, 153 to provide a larger cross-section
adjacent flanged ends 164, 165. When wall portions 140a, 140b of
outer sleeve 101 are moved from their FIG. 8 positioning to their
positioning in FIGS. 9 and 10, wall portions 140a, 140b can contact
intermediate portions 186, 187 to facilitate positive closure of
the flanged ends 164, 165 against anchor 300.
[0055] As also shown in FIG. 15, the proximal end portion 174 of
body 158 includes an externally threaded section 178 for engagement
by reducing actuator 122. Accordingly, rotation of reducing
actuator 122 along threaded section 178 causes axial displacement
of inner and outer sleeves 101, 150 relative to one another.
Threaded section 178 further includes an outer wall surface having
opposing, non-threaded flats 180a, 180b extending therealong and
also distally therefrom along a portion of the length of body 158.
A recess 182a, 182b is formed in each of the flats 180a, 180b, and
a protrusion 184a, 184b extends outwardly from the respective flats
180a, 180b adjacent to and proximally of the respective recess
182a, 182b.
[0056] Buttons 116 can be elongated and extend axially along
extension 100. Each button 116 can include a proximal end with a
first distal projection 117 and a second proximal projection 119,
as shown in FIGS. 8 and 9. A spring member 125 can bias button 116
about its pivotal connection 121 with outer sleeve 101 so that
projections 117, 119 are normally pivoted toward inner sleeve 150.
In the starting configuration of FIGS. 9-10, distal projection 117
is received in the respective adjacent recess 182a, 182b and the
proximal projection 119 is positioned proximally of the respective
adjacent protrusion 184a, 184b. In this configuration, the contact
between projection 119 and the respective protrusion 184a, 184b
prevents proximal movement of inner sleeve 150 relative to outer
sleeve 101, and the contact between distal projection 117 and the
respective recess 182a, 182b prevents inner sleeve 150 from moving
distally relative to outer sleeve 101.
[0057] Buttons 116 can be depressed and rotated against the bias of
spring 125 about connection 121 so that the projections 117, 119
cannot interfere with inner sleeve 150, and inner sleeve 150 can be
displaced distally relative to outer sleeve 101 to a loading
configuration, as shown in FIG. 8. In this configuration, arms 154,
155 can be flexed apart and so that flanged ends 164, 165 can be
positioned on opposing sides of the respective anchor 300. To
firmly clamp flanged ends 164, 165 to the anchor 300, inner sleeve
150 is displaced proximally relative to outer sleeve 101 to the
starting configuration shown in FIGS. 9-10. In this configuration,
distal end portion 105 contacts the outer surfaces of flanged ends
164, 165 to prevent arms 154, 155 from moving apart and tightly
grips flanged ends 164, 165 to the anchor 300.
[0058] From the starting configuration, inner sleeve 150 can be
moved proximally relative to outer sleeve 101 so that distal
projecting members 106a, 106b contact connecting element 200
extending in space 102 transversely to flanged ends 164, 165.
Advancement of connecting element 200 into contact with projecting
members 106a, 106b is accomplished by rotating reducing actuator
122 about threaded end section 178 of inner sleeve 150, as shown in
FIG. 11, until connecting element 200 is firmly seated in the
connecting element engaging portion 304 of anchor 300. A set screw
or other engaging member can be delivered through passage 190 of
inner sleeve 150 and engaged to connecting element engaging portion
304 to engage and maintain connecting element 200 therein.
[0059] To permit proximal displacement of inner sleeve 150 from its
starting configuration without depressing button 116, recesses
182a, 182 include distally sloped wall portions 183a, 183b, as
shown in FIG. 15, that contact correspondingly shaped distally
sloped wall portions of the respective adjacent distal projection
117. As inner sleeve 150 is initially moved proximally relative to
outer sleeve 101 from the starting configuration of FIGS. 9-10, the
sloped wall portions slide along one another to pivot button 116
about its connection 121 and move the proximal end of button 116,
and thus proximal projection 119, away from inner sleeve 150 so
that proximal projection 119 cannot contact the respective
protrusion 184a, 184b extending from inner sleeve 150. Projection
117 can slide along the respective adjacent non-threaded flat wall
surface 180a, 180b as inner sleeve 150 is advanced further
proximally relative to outer sleeve 101.
[0060] Inner sleeve 150 can include calibrations or other
indicators on its outer surface to provide an indication of the
configuration of the inner sleeve relative to the outer sleeve.
Such indicators can be provided on inner sleeve 150 and visualized
through one or both of the proximal slots 130a, 130b of outer
sleeve 101 to provide visual cues of the configuration of extension
100. For example, one indicator can indicate that the extension 100
is in the loading configuration for engaging anchor 300 to arms
154, 155, as shown in FIG. 8. Another indicator can indicate that
the extension is in the starting configuration as shown in FIGS. 9
and 10. In the starting configuration, anchor 300 is securely
engaged between flanged ends 164, 165 but outer sleeve 101 is
positioned proximally of anchor 300 to form space 102 to receive
connecting element 200 between flanged ends 164, 165 proximal of
the anchor. Space 102 can be elongated to provide a location
adjacent to anchors 300, in addition to the connecting element
engaging portions 304, in which the connecting element 200 can be
initially positioned relative to the anchors 300, and connecting
element 200 need not be guided directly into the connecting element
engaging portion 304. A third indicator can indicate that
connecting element 200 is seated in anchor 300 since inner sleeve
150 is displaced proximally relative to outer sleeve 101 to force
connecting element 200 into the connecting element engaging portion
304 of anchor 300.
[0061] In order to uncouple extension 100 from anchor 300 after
seating and securing connecting element 200 in anchor 300, reducing
actuator 122 is rotated in the opposite direction to proximally
displace outer sleeve 101 along inner sleeve 150 until extension
100 is in its starting configuration. With reducing actuator 122
not engaged to threaded section 178, buttons 116 can then be
pressed to disengage inner sleeve 150 and allow outer sleeve 101 to
slide freely proximally relative to inner sleeve 150 to the loading
configuration of FIG. 8. Arms 154, 155 can then flex outwardly away
from one another as the extension 100 is pulled off of anchor 300
to disengage anchor 300 from between flanged ends 164, 165.
[0062] Various surgical techniques can be completed with system 10.
One type of surgical technique is directed to spinal surgery for
positioning an elongated connecting element along one or more
vertebral levels to provide spinal stabilization. A number of
anchors 300 are selected according to the number of vertebral
levels to be instrumented. For example, a single level procedure
may include an anchor engaged to each of two vertebrae, or a two
level procedure may include an anchor engaged to each of three
vertebrae.
[0063] When the desired number of levels has been selected, anchors
300 can be engaged to the respective vertebrae. In posterior spinal
surgical techniques, the anchors 300 can be screws engaged in the
pedicles of the vertebrae. Anchors 300 can be positioned into the
patient through one or more minimally invasive access portals,
formed by an incision, cannula, or retractor system, for example.
Extensions 100 can be clamped to the anchors after the anchors are
engaged to the vertebrae. Alternatively, the anchors can be clamped
to the extensions, and then delivered through the access portal or
portals for engagement with the respective vertebrae. Placement of
the anchors can be facilitated using a guide wire, image guided
surgery system, fluoroscopic imaging, computer assisted surgical
navigation, X-rays, CT scans, endoscopic viewing systems,
microscopic viewing systems, loupes, and/or naked eye
visualization, for example.
[0064] With the anchors 300 engaged to the vertebrae and with
extensions 100 extending therefrom, extensions 100 have a length
sufficient to extend from the patient so that their proximal ends
are accessible for grasping and pivoting or application of forces
to facilitate alignment of the connecting element engaging portions
304 of the anchors 300. For example, distraction, compression or
torsional forces can be provided to one or more of the extensions
100 to provide a desired effect to the vertebrae either before of
after placement of the connecting element between the anchors.
[0065] The connecting element 200 can enter the patient
percutaneously or through a retracted opening from an entry
location remote from the extensions. The connecting element is
guided by the surgeon through the tissue to a location adjacent the
nearest anchor 300 and anchor extension 100 and into the space 102
defined thereby. The connecting element can then be serially
advanced through the other spaces 102 defined by the other anchors
300 and extensions 100. Placement of the connecting element 200 can
be facilitated using a guide wire, image guided surgery system,
fluoroscopic imaging, computer assisted surgical navigation,
X-rays, CT scans, endoscopic viewing systems, microscopic viewing
systems, loupes, and/or naked eye visualization, for example. One
or more sensors can be provided in or on the connecting element 200
to assist in tracking its location in the patient. For example, a
magnetic tracking coil could be mounted on a wire and placed in a
cannulation of the connecting element near its distal leading end.
Electromagnetic surgical navigation of placement of the connecting
element into the patient's body can then be carried out. In
addition, tactile cues can be provided to the surgeon assist
placement in the space between the extension and anchor if and when
the connecting element contacts the anchor or extension.
[0066] Prior to placement of connecting element 200, a trocar can
be engaged to inserter instrument 20 and moved into the patient
from a location outside the patient, through skin and/or tissue of
the patient, and to at least one of the anchors 300. Inserter
instrument 20 can be withdrawn in the reverse direction to withdraw
the trocar. The trocar can then be removed from inserter instrument
20, and connecting element 200 engaged to inserter instrument 20 to
move it along the insertion path formed in the patient by the
trocar until the connecting element extends between anchors 300. It
is further contemplated that the leading end of connecting element
200 can be tapered or pointed to facilitate puncture and/or
tunneling through the skin and tissue of the patient, either to
form a path or to be inserted along a path formed by a trocar.
Placement of the trocar and/or connecting element 200 can be
monitored and/or confirmed using any of the visualization
techniques discussed above.
[0067] Connecting element 200 can be remotely disengaged from
inserter instrument 20 by manipulating actuating member 30 to
release engaging end 40 of locking mechanism 34 from connecting
element 200. Inserter instrument 20 can then be withdrawn from the
patient by pulling it with handle portion 24 in the reverse
direction along the insertion path. Set screws or other engaging
members can be delivered through extensions 100 with a driving
instrument, and engaged with respective ones of the anchors 300 to
secure connecting element 200 to anchors 300. Extensions 100 can
then be unclamped from the respective anchors 300 by depressing
buttons 116 and allowing the outer sleeve to slide proximally
relative to inner sleeve, releasing arms from engagement with
connecting element engaging portion 34 of anchor 300. Should any of
the extensions 100 be employed for reduction of the connecting
element into the anchors, the corresponding extensions are first
moved from the seating configuration to the starting configuration
before unlocking with buttons 116.
[0068] One or more other connecting elements can be similarly
engaged to the spinal column along the same vertebral level or
levels, or along other vertebral levels. Other procedures can also
be completed in conjunction with the stabilization procedure,
including discectomy, interbody fusion, artificial disc
replacement, bone removal, tissue removal, intravertebral
reduction, joint replacement, annular repair, and/or any other
spinal surgical procedures.
[0069] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character, it
being understood that all changes and modifications that come
within the spirit of the invention are desired to be protected.
* * * * *